Freelancer profile translated to English.

Description

Strategic and operational support for regulatory compliance and quality management

Specializing in medical devices, I work with manufacturers, authorized representatives, or subcontractors to secure market access, maintain regulatory compliance, and optimize quality management systems (QMS).

My areas of expertise:

Regulatory Compliance: MDR 2017/745, ISO 13485, MDSAP

Product registration and post-market surveillance (vigilance, PMS, PMCF)

Technical documentation writing/validation (Technical File, CER, IFU, etc.)

Preparation and support for audits (certification, surveillance)

QMS implementation and improvement (ISO 13485, custom-tailored)

CE marking strategy, classification, clinical evaluation, and biocompatibility

Collaboration format:

One-off or recurring missions

Full outsourcing or project support

Work in French or English

Based in Paris, I work remotely or on-site according to your needs. My goal: to enable you to move forward in full compliance, pragmatically and efficiently.

Languages

English
Native or bilingual
Spanish
Basic
Arabic
Conversational

Workplace preferences

Can work on-site

Paris (up to 50km)

Permobil
QA Manager France - Freelance
MEDICAL
January 2026 - Today (5 months)
Implementation of distributor QMS and monitoring of each site to ensure compliance with the various MDR 2017/745 obligations specific to distributors.
MDR 2017/745 Quality ISO 13485 Interpersonal Skills Project Management
Laboratoires Théa
Regulatory Affairs Officer - Medical Devices
September 2024 - September 2025 (1 year)
Preparation and management of registration files for new products as well as those already on the market. Participation in the planning of Regulatory Affairs and Registration activities, analysis of regulatory requirements, and development of specifications for file preparation. Continuous regulatory monitoring for assigned countries and/or defined topics. Organization, planning, and follow-up of file submissions in coordination with Health Authorities and local partners.
Directive 98/282/EC MDR 2017/745 Risk Analysis
Muller Medical
Quality and Regulatory Affairs Officer
March 2024 - August 2024 (5 months)
Implementation of NF EN ISO 13485, ISO 14971, ISO 15001, ISO 15002, and ISO 62366-1 standards within the framework of quality and compliance processes. Monitoring of CAPAs and customer complaints to ensure compliance and customer satisfaction. Drafting and updating of quality and regulatory documents for the transition to the MDR regulation (FMEA, GSPR, PSUR, etc.).